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Patient Instruction Booklet DAILIES TOTAL1® (delefilcon A) Soft Contact Lenses For Single-Use, Daily Disposable Wear *High O2 Permeable Lenses, Dk=140 Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed eye care professional e This pag left y l l a n o i t n inte 2 blank Table of Contents Introduction..................................................................................... Commonly Used Terms................................................................... Warnings and Precautions.............................................................. What You Should Know About Contact Lens Wear................... Adverse Effects (Possible Problems).......................................... What To Do if a Problem Occurs................................................ When Lenses Should Not Be Worn................................................. General Guidelines for Safe Contact Lens Wear............................. Wearing Your Lenses.................................................................. When To Remove Your Lenses................................................... Cosmetic Products and Your Lenses......................................... Other Eye Care Products and Medications................................ How to Place the Lens on Your Eye................................................ The Importance of a Clean Start................................................ Steps 1-2.................................................................................... The Lens Package...................................................................... Steps 3-5.................................................................................... Centering the Lens..................................................................... How to Remove the Lens From Your Eye....................................... Steps 1-6.................................................................................... Other Important Information............................................................ Lens and Packaging Solution..................................................... Follow-up Care........................................................................... Using Wetting Drops (Lens Lubricants)...................................... If a Lens Dries Out...................................................................... Care for a Sticking Lens............................................................. Emergencies............................................................................... Lenses for Different Vision Conditions............................................ Instructions for the Monovision Wearer (Spherical)......................... Wearer Information.......................................................................... 3 5 6 7 7 8 9 9 9 9 11 11 11 12 12 12 13 13 16 16 17 18 18 18 18 18 18 19 19 20 21 ft blank nally le e intentio This pag 4 INTRODUCTION Welcome! DAILIES TOTAL1® One-Day CONTACT LENSES: Designed for exceptional comfort from the beginning to the end of the day. Thank you for choosing CIBA Vision DAILIES TOTAL1® contact lenses from Alcon, leaders in eyecare and vision correction. DAILIES TOTAL1® contact lenses are made from a breathable silicone hydrogel material that is soft and flexible. In addition, DAILIES TOTAL1® contact lenses were designed with a technologically advanced, highly wettable surface. DAILIES TOTAL1® contact lenses are designed to have high levels of oxygen transmissibility – which translated – means your eyes will be getting oxygen while you’re wearing them, helping to keep them feeling refreshed and healthy looking. And since DAILIES TOTAL1® contact lenses are daily disposables, you get a fresh, new lens every day making them the most hygienic way to wear contact lenses. DAILIES TOTAL1® contact lenses - About This Booklet This booklet explains how to safely use your DAILIES TOTAL1® contact lenses. Please read it carefully and keep it in a safe place for future reference. If you have questions after reading this booklet, call or visit your eye care professional. Also, you may call Medical Product Information toll free in the USA at 1-800-875-3001. In addition to the information presented in this booklet, please be sure to follow the recommendations of your eye care professional for successful and safe contact lens wear. If you do not, you may: •increase the chances of serious eye infection and injury •cause damage to your contact lenses 5 COMMONLY USED TERMS Here are some useful definitions for terms regularly used when speaking about contact lenses and vision conditions. Cornea The clear front part of the eye, permitting light to enter. The cornea is located in front of the iris and pupil. • Iris - The colored part of the eye which controls the size of the pupil •Pupil - The black round opening surrounded by the iris Lens Deposits Contaminants such as cosmetics, lotions, protein from the tear film, environmental pollutants, etc., which collects on the lens surface. Daily Wear Contact lens wear for less than 24 hours a day, while awake. Normal daily wear of contact lenses assumes a minimum 6-hour period of non-lens wear each day. Individual wearing times will vary. Daily Disposable A contact lens wear and replacement schedule where fresh, sterile, new lenses are inserted each time lenses are worn and thrown out at the end of each wearing day. The following may appear on the labels or cartons: Symbol/Sign EXP en Description Symbol/Sign CAUTION: Federal (United States) law restricts this device to sale by or on the order of a licensed eye care professional. DIA Diameter BC Base curve D Description Diopter (lens power) Steam sterilized European conformity sign Use by date (Expiry date) See product instructions Batch code Authorized Representative European Community Example of two letter language code (English) Manufacturer Do not reuse Packaging waste license sign Do Not Reuse 6 An Important Note About Your Contact Lenses DAILIES TOTAL1® (delefilcon A) lenses are daily disposable lenses and are not intended to be cleaned or disinfected. Lenses should be discarded after a single use. Your eye care professional will determine the number of lenses you will need, how long you should wear your lenses each day and when to rest your eyes. You should also discuss with your eye care professional the frequency of follow-up care. WARNINGS AND PRECAUTIONS DAILIES TOTAL1® contact lenses are offer remarkable convenience and outstanding comfort; however, there are some precautions you should take in order to ensure a safe and healthy wearing experience. What You Should Know About Contact Lens Wear Warning Serious injury to the eye, scarring of the cornea, and loss of vision may result from problems associated with wearing contact lenses. Eye problems, including corneal ulcers, can develop rapidly and lead to loss of vision. Immediately call or visit your eye care professional for persistent symptoms of any eye discomfort, watering, and vision change, or redness. Be Aware of the Following: • Do not sleep in your DAILIES TOTAL1® contact lenses - Overnight wear of contact lenses has been shown to increase the risk of certain serious contact lens related complications. The risk increases with the number of days in a row that lenses are worn between removals, beginning with the first overnight use. - When daily wear users wear their lenses overnight (outside the approved indication) the risk of ulcerative keratitis is nine times greater than among those who do not wear them overnight. • Be sure to inform your eye care professional if you smoke -Smoking increases the risk of serious problems with contact lens wear. 7 Follow Directions: Be sure to follow exactly the instructions of your eye care professional and manufacturers’ labeled instructions for the proper use of your contact lenses. Failure to do so may put you at significant risk of developing serious eye problems. Do not use saliva, tap water, distilled water, or homemade saline solution for any purpose in caring for your lenses. The use of these solutions has been associated with serious eye infections including Acanthamoeba keratitis, a corneal infection which is resistant to treatment and cure. Adverse Effects (Possible Problems) It is possible that problems can occur and may be accompanied by one or more of the following conditions: • Moderate to severe eye pain not relieved by removing the lens • Feeling of something in the eye • Unusual eye secretions • Eye redness • Sensitivity to light (photophobia) • Eyes burn, sting or itch • Eyes water • Reduced sharpness of vision • Rainbows or halos around objects • Uncomfortable lens • Feeling of dryness 8 Occasionally a serious condition such as corneal ulcer or eye infection may be present and may progress rapidly. Even less serious reactions such as a scratched cornea must be treated promptly to avoid more serious complications. What To Do if a Problem Occurs If you experience any of the above signs or symptoms, immediately remove your lens(es). If the discomfort stops, insert a fresh new lens. If the problem continues, immediately remove your lens(es) and contact your eye care professional at once. Even less serious reactions must be treated promptly to avoid more serious complications. WHEN LENSES SHOULD NOT BE WORN Contact lenses should not be worn under certain general health and eye conditions. Only your eye care professional can determine if continued contact lens wear is right for you. These include the following: • Inflammation or infection in or around the eye or eyelids. •Excessive dryness of the eyes that makes contact lens wear uncomfortable. • If eyes become red or irritated. • Any condition which reduces corneal sensitivity. • Systemic diseases that may be affected by or impact lens wear. •Allergic conditions, reactions or ocular irritation caused or exaggerated by lens wear or certain preservatives in lens care products. •The use of any medication, including some eye medications, that shouldn’t be used with, or interferes with contact lens wear. GENERAL GUIDELINES FOR SAFE CONTACT LENS WEAR Wearing Your Lenses Check your eyes regularly. While wearing your DAILIES TOTAL1® contact lenses your eyes should look well, feel comfortable and your vision should be clear. • Always clean, rinse and dry your hands thoroughly with a lint-free towel before handling your lenses. 9 •Your lenses are provided to you in foil sealed tamper-evident blister pack containers. Never use a lens if the container seal is broken, as damage or contamination may have occurred. • Don’t wear your lenses longer than recommended by your eye care professional, no matter how comfortable the lenses feel. Doing so increases the risk of adverse effects. •Don’t excessively rub your eyes while the lenses are in. You may harm your eyes or damage the lens. •Don’t get water, soap, or shampoo into your eyes during a bath or shower. These substances could get on your lenses and irritate your eyes. • Be aware that hot and windy conditions may dry out your lenses. For example, air from a hair dryer, ceiling fan, or open car window may dry out your lenses and irritate your eyes. •Always inform your eye care professional, physician and employer that you wear contact lenses. Contact lenses may not be used with certain medications or medical procedures, may not be suitable for certain occupations, or may require eye protection equipment. •Exposure to water while wearing contact lenses in activities such as swimming, water skiing and hot tubs may increase the risk of: •eye infection, including but not limited to Acanthamoeba keratitis • damage to the lenses by chemicals in the water • loss of the lenses •Consult your eye care professional about wearing lenses during sporting and water related activities. •DO NOT USE saliva, tap water, distilled water, or homemade saline solutions to care for or when handling your lenses. •Tasks requiring visual concentration such as working at a computer may cause your eyes to feel dry. If this occurs, look away at frequent intervals and blink often. • Do not use lenses that have passed their expiration date. • Make note of the correct lens power for each eye to avoid getting them switched. • Discard any lens that has become dried out or damaged. Replace it with a fresh, new lens. • Always keep a spare pair of lenses with you. 10 When to Remove Your Lenses •Do not wear your lenses for longer periods each day than your eye care professional has recommended, and don’t nap or sleep overnight in the lenses. Sleeping with lenses on increases the risk of eye infection. •Remove your lenses immediately if they become uncomfortable. Discomfort can be an early warning sign of a more serious problem. If the discomfort continues after lens removal, contact your eye care professional. Early treatment can help avoid more serious complications. •Remove your lenses if you will be in the presence of irritating liquids, gases, chemicals, or smoke. Your lenses can become damaged by absorbing these substances and irritate or injure your eyes. If exposed to these substances while wearing your lenses, see the section titled “Emergencies” in the back of this booklet. Cosmetic Products and Your Lenses •Lens damage, eye irritation or infection may result if cosmetics, lotion, soap, cream, hair spray, deodorant, perfume, or aerosol products come in contact with your lenses. If sprays are used, close your eyes until the spray has settled. •Insert lenses before applying make-up and remove lenses before taking your make-up off. Make-up can become trapped under the lens and irritate or injure your eyes. •Do not use nail polish remover while wearing your lenses. The fumes can damage the lenses. Other Eye Care Products and Medications •Do not use eye drops, solutions, or medications in your eyes unless directed by your eye care professional. These solutions may damage your lenses or irritate your eyes. You may use lens rewetting drops while lenses are worn as recommended by the eye care professional. • Certain medications may cause blurred vision, lens dryness, or lens discomfort. These include antihistamines, decongestants, diuretics, muscle relaxants, oral contraceptives, tranquilizers, and motion sickness medications. Always inform your eye care professional if you experience any problems with your lenses while taking such medications. 11 HOW TO PLACE THE LENS ON YOUR EYE The Importance of a Clean Start Cleanliness is one of the most important aspects of handling and caring for your contact lenses. Starting with clean, dry hands helps to reduce the chance of eye infections and irritation. Step 1 – Wash, Rinse, and Dry Hands Thoroughly • Always wash your hands thoroughly with soap that does not have any oils, lotions, or perfumes. • Thorough hand washing will remove dirt, germs, and oils that could get on the lenses and cause irritation or infection. Using the proper soap prevents chemical residues from getting on the lenses. • Rinse your hands thoroughly Always wash your hands before after washing. handling your lenses. This will • This removes all traces of remove dirt and oils that could get on the lenses. Proper hand soap and dirt. washing also helps prevent eye • Dry your hands thoroughly infections. with a lint-free towel. • This helps keep lint and dust from getting on your lenses and irritating your eyes. • Long fingernails can make lens placement, removal and cleaning more difficult. Sharp, rough fingernails can damage the lenses. Step 2 – Open the Multipack Carton and Lens Container DAILIES TOTAL1® contact lenses are supplied sterile in multipack cartons with individual foil sealed plastic containers. Five blister packs are attached to form a single strip. Locate the opening flap on the multipack carton and pull up to break the seal. Each multipack carton and lens container is marked with the lens power (your vision prescription). Lens powers may not be the same for both eyes, so multipack cartons have a check box for your eye care professional to mark indicating which lens if for your left and right eye. Be sure to open and use the correct lens for each eye. 12 The Lens Package Each DAILIES TOTAL1® contact lens is supplied in a foil sealed plastic container designed to maintain sterility of the lens and package saline solution. To open an individual container, follow these simple steps: 1.Shake the lens package gently, and peel back lid. 2.Carefully remove the lens from package. • With a clean finger, gently slide the lens out of the lens container or pour the lens onto the palm of your clean hand. • Do not use tweezers or other tools to remove the lens from container. This could damage the lens. Step 3 – Inspect the Lens for Damage or Foreign Matter • Examine the lens to be sure it is clean and moist and free of damage. • Place the lens on the tip of your index finger and hold it up against a bright light. Never handle your lenses over a sink with an open drain. Shut the drain or place a clean paper towel over the opening to keep from losing your lenses. • If the lens appears damaged or dried out, do not use it. Discard it and use the next lens in the multipack. Step 4 – Make Sure the Lens Is Right Side Out Check to see that your lens is right side out. A lens that is placed on the eye inside out may not feel comfortable or provide good vision. Do the Taco Test One way to do this is to place the lens between your thumb and index finger and gently squeeze the edges together by pressing on the sides of the lens as shown in the picture below. • If the edges come together, the lens is right side out. • If the edges turn outward, the lens is wrong side out. Carefully reverse it with your fingers. 13 Another way to do the “taco test” is to place the lens between a skin crease in the palm of your hand and gently closing your hand. Do the Finger Test A second way to tell if a lens is right side out is to place the lens on the tip of your index finger and check its shape. • If the edge appears bowl-shaped, it is right side out. • If the edge has a lip or flares outward, it is wrong side out and must be reversed. Step 5 – Place Lens on Eye After you have thoroughly washed, rinsed, and dried your hands, rinsed and inspected the lens, and made sure it is right side out, you are ready to place the lens on your eye. Remember to start with the same lens first (right or left), then the other lens. This helps avoid getting the lenses mixed up. 1.Place the lens on the tip of your right index finger (left index finger if you are left-handed and this is easier for you). Make sure your finger is completely dry, or the lens will stick to your finger and be difficult to transfer to your eye. 2.Place the middle finger of the same hand close to your lower eyelashes and pull down the lower eyelid. 3.Use the fingers of the other hand to lift the upper right eyelid. 14 4.Place the lens directly on the eye (cornea) by gently rolling it off the index finger. 5.Look down and slowly remove your right hand, releasing the lower lid. 6.Look straight ahead and slowly remove your left hand, releasing the upper lid. 7.Blink gently. The lens should center automatically. 8.Repeat steps 1-7 above for the other lens. Your eye care professional may suggest alternate methods for insertion of the lens onto the eye. If your vision is blurred or the lens is uncomfortable on your eye, check for the following: • The lens is not centered on the eye (see Centering the Lens, next section) •The lens is centered. Remove the lens (see Lens Removal section) and check for the following: • Cosmetics, oils, or particles on the lens. Rinse the lens with the remaining liquid in the blister pack and place on the eye again or use a new lens. • The lens is on the wrong eye. • The lens is wrong side out. • The lens may be torn or damaged. If so, do not place the lens back on your eye. Discard the lens and replace it with a new lens. If your vision is still blurred or the lens is uncomfortable after checking the above, remove both lenses and contact your eye care professional. After you have successfully inserted your lenses, you should ask yourself: • Do the lenses feel good? (There should be no discomfort.) • Do my eyes look good? (Your eyes should not be red or swollen or have any discharge.) 15 •Is my vision good? (You should be able to see clearly out of each eye individually and together.) If the answer to any of these questions is no, immediately remove your lenses and contact your eye care professional. Centering the Lens Occasionally a lens will be displaced onto the white part of the eye during lens placement or during lens wear. To center a lens, follow one of the methods below: Method 1. Look in the direction of the displaced lens. Blink gently. The lens should automatically move toward the center of the eye and into the correct position. Method 2. Close your eyelids and gently massage the lens into place through the closed eyelid. Method 3. Gently push the off-centered lens onto the cornea with the eye open, using gentle finger pressure on the edge of the upper or lower eyelid. HOW TO REMOVE THE LENS FROM YOUR EYE Remember to remove the same lens first (right or left), then the other lens. This helps avoid getting the lenses mixed up. Step 1 - Wash, Rinse, and Dry Hands • Wash your hands thoroughly with soap that does not have any oils, lotions, or perfumes. • Dry your hands thoroughly with a lint-free towel. If your fingertips are wet they are likely to slip across the surface of the lens making removal more difficult. The surfaces of your DAILIES TOTAL1® contact lenses are designed to stay very wet and slippery (lubricious) while on eye. For easy lens removal make sure you have thoroughly dried your hands. 16 Step 2 - Make Sure Lens is on the Eye Make sure the lens is centered on your eye before trying to remove it. Cover the other eye; if your vision is blurred, the lens is either off center or not on the eye at all. Locate the lens with a mirror and re-center it using one of the methods described in the section, Centering the Lens. Step 3 - Pull Down Lower Eyelid Look upward, keeping your head level. Pull down the lower lid of your eye with your middle finger. Step 4 - Slide Lens Down While looking up, place the tip of your index finger on the lower edge of the lens and slide it down onto the lower white part of your eye. Step 5 - Pull Lens Off Eye Still looking up, squeeze the lens gently between your thumb and index finger. Gently remove the lens from the eye. If the lens is difficult to grasp, dry fingers once more and try again. Do not use rewetting drops in this instance. Step 6 – Discard the Lens Repeat Steps 2-6 for the other lens If a lens tears in your eye it will feel uncomfortable. Remain calm as it is impossible to lose a contact lens or part of a contact lens behind the eye. Remove lens pieces by pinching them as you would do for normal lens removal, carefully avoiding pinching the eye tissue. If the lens pieces do not seem to remove easily, rinsing with saline is recommended. If this does not help, contact your eye care professional for assistance. 17 OTHER IMPORTANT INFORMATION Lens and Packaging Saline DAILIES TOTAL1® contact lenses are 67% delefilcon A and 33% water, with phosphatidylcholine. The lenses contain the color additive copper phthalocyanine, a light blue tint which makes them easier to see when handling. Lenses are provided sterile in blister packs containing buffered saline with approximately 0.3% of polymeric wetting agents consisting of copolymers of polyamidoamine and poly(acryamid-acrylic acid). Follow-up Care •Do not skip visits with your eye care professional just because your lenses feel comfortable. Routine follow-up visits help prevent problems. A thorough examination by your eye care professional is important to determine how your eyes are responding to contact lenses. Early signs of a problem can be detected and treated before you can feel them. It is recommended contact lens wearers see their eye care professional once each year, or more often, as directed by the eye care professional. Using Lens Wetting Drops (Lens Lubricant) •If wetting drops are recommended by your eye care professional, follow the directions for use provided by the manufacturer. Not all lens lubricants can be used with soft contact lenses. If a Lens Dries Out •If a lens is exposed to air while off the eye it may become dry, brittle, and permanently damaged. If this should occur, discard the lens and use a new one to avoid possible irritation or injury to the eye. Care for a Sticking Lens • Make sure your hands are clean and dry before removing lenses. •In the unlikely event that a lens sticks (stops moving) or begins to dry on the eye, apply a lubricating solution recommended for soft lenses according to the manufacturer’s instruction for use. •Wait until the lens begins to move freely on the eye before trying to remove it. If the lens continues to stick, IMMEDIATELY consult your eye care professional. 18 Emergencies •If chemicals of any kind (household cleaners, gardening solutions, laboratory chemicals, pesticides, etc.) are splashed into the eyes: • Flush eyes immediately with tap water or fresh saline solution. • Remove and discard the lenses. • Call or visit your eye care professional or a hospital emergency room immediately. LENSES FOR DIFFERENT VISION CONDITIONS DAILIES TOTAL1® contact lenses are available in a spherical lens design to correct nearsightedness (myopia) or farsightedness (hyperopia). In addition, lenses come in a range of prescriptive powers. Your eye care professional will prescribe the prescriptive power (Rx) that’s needed to correct vision in your right and left eye. 19 INSTRUCTIONS FOR THE MONOVISION WEARER (SPHERICAL) •You should be aware that as with any type of lens correction, there are advantages and compromises to monovision contact lens therapy. The benefit of clear near vision in straight ahead and upward gaze that is available with monovision may be accompanied by a vision compromise that may reduce your distance visual acuity and depth perception for distance and near tasks. Some patients have experienced difficulty adapting to it. Symptoms, such as mild blurred vision, dizziness, headaches and a feeling of slight imbalance, may last for a brief minute or for several weeks as adaptation takes place. The longer these symptoms persist, the poorer your prognosis for successful adaptation. You should avoid visually demanding situations during the initial adaptation period. It is recommended that you first wear these contact lenses in familiar situations, which are not visually demanding. For example, it might be better to be a passenger, rather than a driver of an automobile, during the first few days of lens wear. It is recommended that you drive with monovision correction only if you pass the driver’s license requirements with your monovision correction. • Some monovision patients will never be fully comfortable functioning under low levels of illumination, such as driving at night. If this happens, you may want to discuss with your eye care professional having additional contact lenses prescribed so that both eyes are corrected for distance when sharp distance binocular vision is required. • If you require very sharp near vision during prolonged close work, you may want to have additional lenses prescribed so that both eyes are corrected for near when sharp near vision binocular vision is required. •Some monovision patients require supplemental spectacles to wear over the monovision contact lens correction to provide the clearest vision for critical tasks. You should discuss this with your eye care professional. •It is important that you follow your eye care professional’s suggestions for adaptation to monovision contact lens therapy. You should discuss any concerns that you may have during and after the adaptation period. •The decision to be fit with a monovision correction is most appropriately left to the eye care professional in conjunction with you, after carefully considering and discussing your needs. 20 WEARER INFORMATION Eye Care Professional: Contact Lens Information: Name: Lens Brand/Type: Street: Prescription/Date: City/State/Zip: Phone: Wear and Replacement Schedules: DAILIES TOTAL1® contact lenses are for single-use, daily disposable wear only. Your eye care professional will determine how many hours in a day and how often you can wear contact lenses. Daily Disposable Wear Only (less than one day, while awake): DO NOT SLEEP in lenses Initial Wearing Schedule: DAYDATE Wearing DAY DATE Wearing (Month/Day) Time (Month/Day) Time (# Hours) (# Hours) 1 6 2 7 3 8 4 9 5 10 Lens Care Supplies (Product Name or Manufacturer): Lens Wetting Drops: APPOINTMENT SCHEDULE: Date: Time: Date: Time: Date: Time: Date: Time: Important: In the event that you experience difficulty wearing your lenses or do not understand the instructions given you, DO NOT WAIT for your next appointment. Phone your eye care professional immediately. 21 lank left b y l l a n o i t nten ei This pag 22 lank left b y l l a n o i t nten ei This pag 23 Manufactured for Alcon by CIBA Vision CIBA Vision Corporation Alcon Laboratories, Inc. 11460 Johns Creek Parkway 6201 South Freeway Duluth, GA, USA 30097 Fort Worth, TX, USA 76134 © 2012 Novartis Date: July 2012 Part #: 92013816